A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate Hydrate

Pharmacokinetic Study of ASP1517 - Evaluation of the Effect of Lanthanum Carbonate Hydrate on the Pharmacokinetics of ASP1517 in Non-elderly Healthy Adult Male Subjects -

The objective of this study is to evaluate the effect of lanthanum carbonate hydrate on the pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: ASP1517; Drug: Lanthanum carbonate hydrate

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Site JP00001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Body weight (at screening): ≥50.0 kg and <80.0 kg
• Body-mass index (at screening): ≥17.6 and <26.4 kg/m2 [Body-mass index = Body weight (kg)/(Height (m))2]
• Subject must agree to use contraception consisting of two established forms specified below starting at the time of informed consent and continuing throughout the treatment period and for 84 days after the last administration of ASP1517.
• Subject must agree not to donate sperm starting at the time of informed consent and continuing throughout 84 days after the last administration of ASP1517.

Exclusion Criteria:

• Received or is scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or during the period from screening to the hospital admission day of the Period 1.
• Received or is scheduled to receive medications (including over-the-counter drugs) or supplements within 7 days before the hospital admission day of the Period 1.
• Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram at screening or the hospital admission day of the Period 1.
• Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 1. Normal ranges of each test specified at the study site or the test/assay organization will be used as the normal ranges in this study.
• Concurrent or previous drug allergies.
• Development of (an) upper gastrointestinal symptom(s) within 7 days before the hospital admission day of the Period 1.
• Concurrent or previous hepatic disease, heart disease, respiratory disease, peritoneum inflammation.
• A history of abdominal surgery, digestive tract excision.
• Concurrent or previous renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions.
• Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311 (FG-2216), erythropoietin products or lanthanum carbonate hydrate.
• Excessive alcohol or smoking habit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP1517 alone period preceding group; Subjects will receive a single oral dose of ASP1517 alone in period 1, then subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 2.	Drug: ASP1517; Oral dose; Drug: Lanthanum carbonate hydrate; Oral dose; Other Names: Fosrenol
Experimental: ASP1517+lanthanum period preceding group; Subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 1, then subjects will receive a single oral dose of ASP1517 alone in period 2.	Drug: ASP1517; Oral dose; Drug: Lanthanum carbonate hydrate; Oral dose; Other Names: Fosrenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) parameter of ASP1517 in plasma: AUCINF	AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity	Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: AUC24h	AUC24h: Area under the concentration-time curve from the time of dosing to 24h	Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: Cmax	Cmax: Maximum concentration	Up to 72hr after each dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter of ASP1517 in plasma: AUClast	AUC last: Area under the concentration-time curve from the time of dosing to the last measurable concentration	Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: CL/F	CL/F: Apparent total systemic clearance	Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: t1/2	t1/2: Terminal elimination half-life	Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: Lambda z	Lambda z: Terminal elimination rate constant	Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: MRTinf	MRTinf: Mean residence time from the time of dosing extrapolated to time infinity	Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: tmax	tmax : Time of Cmax	Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: tlag	tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration	Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: Vz/F	Vz/F: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing	Up to 72hr after each dosing
Safety assessed by incidence of adverse events		Up to 7 days after drug dosing of period 2
Safety assessed by supine blood pressure		Up to 7 days after drug dosing of period 2
Safety assessed by supine pulse rate		Up to 7 days after drug dosing of period 2
Safety assessed by axillary body temperature		Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Hematology		Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Blood biochemistry		Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Urinalysis		Up to 7 days after drug dosing of period 2
Safety assessed by 12-lead electrocardiogram		Up to 7 days after drug dosing of period 2

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: FibroGen

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Estimate): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Drug-drug interaction; ASP1517
• Other Study ID Numbers: 1517-CL-0205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided